FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
Bloomberg L.P.

FDA Slow Walking a Long-Awaited Abortion Pill Safety Study

The drug is used in nearly two-thirds of US abortions and for miscarriage management, according to the American Civil Liberties Union, which estimates that roughly 7.5 million Americans have taken the ...
Wall Street Journal

Former FDA Chiefs Criticize Agency’s Proposed Vaccine Hurdles

Former Food and Drug Administration commissioners said new vaccine standards threaten to put Americans’ health at risk and upend the agency’s scientific integrity. The 12 former FDA leaders criticized ...
Scientific American

Changing the FDA’s Vaccine Approval Process Could Threaten COVID, Flu Protection for Children

The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, which was written by FDA chief medical and scientific officer Vinay ...
GitHub

Nitrosamine datasets and codes

This is the repository of the jounal paper titled "Integrating Explainable Artificial Intelligence and Carcinogenic Potency Characterization for Safer Nitrosamine Risk Assessment in Drug Synthesis." ...
STAT

FDA review staff was excluded from voting on whether to approve first priority voucher drug

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...
The Columbian

The FDA removes a long-standing warning from hormone-based menopause drugs

WASHINGTON — Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, the Food ...